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EYLEA (aflibercept) Injection For Intravitreal Injection package

EYLEA has been studied in more than 3,000 people with certain diseases of the retina.

EYLEA is a prescription medication given by injection into the eye. You should not use EYLEA if you have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA, including aflibercept.

How EYLEA works

EYLEA is an anti–vascular endothelial growth factor (anti-VEGF) treatment that is given by injection into the eye and works by blocking VEGF. EYLEA blocks VEGF by trapping it between its molecular arms.

EYLEA blocking vascular endothelial growth factor by trapping it between its molecular arms

What is VEGF?

People with Wet AMD have high amounts of VEGF (a type of protein that affects blood vessels).2 At high levels, VEGF can cause abnormal blood vessels to grow under the macula.2 These blood vessels may leak blood or fluid. This damages the macula and can lead to vision loss.2


Support from EYLEA4U®

If you and your eye doctor decide that EYLEA is right for you, we have multiple support options that may be able to help you. Whether you have government insurance (like Medicare), private health insurance, or no coverage for EYLEA, we are here to help.


Vision improvements seen with EYLEA

In 2 clinical studies, 1,815 people with Wet AMD received injections of EYLEA (2 mg) either once every 8 weeks after 3 initial monthly doses or once every 4 weeks or ranibizumab once every 4 weeks.

Both studies measured the percentage of people whose vision was maintained (not losing 15 or more letters, or 3 lines, on the eye chart) at 1 year.

9 out of 10 people with Wet Age-related Macular Degeneration maintained or improved their vision after 1 year of receiving EYLEA every 2 months

Of people treated with EYLEA
in the 2 clinical studies at 1 year,
9 out of 10 maintained their vision at 1 year.

On average, at one year, people treated with EYLEA in the studies gained at least 7 more letters on the eye chart than before treatment.

Vision before EYLEA treatment
Vision after EYLEA treatment

Results from the clinical studies were seen with an average of 7 to 8 treatments of EYLEA 2 mg dosed every 8 weeks (following 3 initial monthly doses) through 1 year.3

These results are from 2 clinical studies; your individual results may vary. Discuss with your eye care team what treatment schedule with EYLEA may be right for you.


Recommended dosing

It's important to keep with your treatment schedule

EYLEA is the only FDA-approved treatment for Wet AMD4 with a recommended dose of 2 mg administered by injection in the eye every 2 months (8 weeks) following 3 initial monthly (every 4 weeks) injections. EYLEA may be dosed once per month, but in most patients, additional benefit was not seen with this dosing plan. Some patients may need monthly (every 4 weeks) dosing after the first 3 months (12 weeks). Your eye care team will determine the EYLEA dosing schedule that's right for you.

Your eye care team will want to see you regularly to check your vision and also check your treatment progress with EYLEA. Work with your eye care team to make sure you can keep your appointments and stay on your recommended treatment schedule.


Safety Information for EYLEA

EYLEA® (aflibercept) Injection is a prescription medication administered by injection into the eye. You should not use EYLEA if you have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA, including aflibercept.

Injection into the eye with EYLEA can result in an infection in the eye and retinal detachment (separation of retina from back of the eye). Inflammation in the eye has been reported with the use of EYLEA.

In some patients, injections with EYLEA may cause a temporary increase in eye pressure within 1 hour of the injection. Sustained increases in eye pressure have been reported with repeated injections, and your doctor may monitor this after each injection.

There is a potential risk of serious and sometimes fatal side effects related to blood clots, leading to heart attack or stroke in patients receiving EYLEA.

Serious side effects related to the injection procedure with EYLEA are rare but can occur including infection inside the eye and retinal detachment.

The most common side effects reported in patients receiving EYLEA are increased redness in the eye, eye pain, cataract, moving spots in the field of vision, increased pressure in the eye, and vitreous (gel-like substance) detachment.

As with all therapeutic proteins, there is a potential for an immune response in patients treated with EYLEA.

It is important that you contact your doctor right away if you think you might be experiencing any side effects, including eye pain or redness, light sensitivity, or blurring of vision, after an injection.

Important Safety Information
  • EYLEA® (aflibercept) Injection is a prescription medication administered by injection into the eye. You should not use EYLEA if you have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA, including aflibercept.
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Important Safety Information
  • EYLEA® (aflibercept) Injection is a prescription medication administered by injection into the eye. You should not use EYLEA if you have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA, including aflibercept.
  • Injection into the eye with EYLEA can result in an infection in the eye and retinal detachment (separation of retina from back of the eye). Inflammation in the eye has been reported with the use of EYLEA.
  • In some patients, injections with EYLEA may cause a temporary increase in eye pressure within 1 hour of the injection. Sustained increases in eye pressure have been reported with repeated injections, and your doctor may monitor this after each injection.
  • There is a potential risk of serious and sometimes fatal side effects related to blood clots, leading to heart attack or stroke in patients receiving EYLEA.
  • Serious side effects related to the injection procedure with EYLEA are rare but can occur including infection inside the eye and retinal detachment.
  • The most common side effects reported in patients receiving EYLEA are increased redness in the eye, eye pain, cataract, moving spots in the field of vision, increased pressure in the eye, and vitreous (gel-like substance) detachment.
  • It is important that you contact your doctor right away if you think you might be experiencing any side effects, including eye pain or redness, light sensitivity, or blurring of vision, after an injection.
  • EYLEA is for prescription use only. For additional safety information, please talk to your doctor and see the full Prescribing Information for EYLEA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Indications

EYLEA® (aflibercept) Injection is a prescription medicine approved for the treatment of patients with:

  • Wet Age-related Macular Degeneration (AMD): The recommended dose for EYLEA is 2 mg administered by injection in the eye every 2 months (8 weeks) following 3 initial monthly (every 4 weeks) injections. EYLEA may be dosed once per month, but in most patients, additional benefit was not seen with this dosing plan. Some patients may need monthly (every 4 weeks) dosing after the first 3 months (12 weeks).
  • Macular Edema following Retinal Vein Occlusion (RVO): The recommended dose for EYLEA is 2 mg administered by injection in the eye monthly (every 4 weeks).
  • Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) in patients with DME: The recommended dose for EYLEA is 2 mg administered by injection in the eye every 2 months (8 weeks) following 5 initial monthly (every 4 weeks) injections. EYLEA may be dosed once per month, but in most patients, additional benefit was not seen with this dosing plan. Some patients may need monthly (every 4 weeks) dosing after the first 5 months (20 weeks).
Please see the full Prescribing Information for EYLEA.

The information contained herein is provided for general educational purposes. If you have any questions, talk to your doctor.

References:
  1. Data on file. Regeneron Pharmaceuticals, Inc.
  2. Facts about age-related macular degeneration. National Institutes of Health, National Eye Institute Web site. https://nei.nih.gov/health/maculardegen/armd_facts. Accessed October 5, 2016.
  3. Heier JS, Brown DM, Chong V, et al; for the VIEW 1 and VIEW 2 Study Groups. Intravitreal aflibercept (VEGF Trap-Eye) in wet age-related macular degeneration. Ophthalmology. 2012;119(12):2537-2548. 
  4. Lucentis® (ranibizumab injection) full U.S. Prescribing Information. Genentech, Inc. October 2016.